| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | QUICKLINK SEED-TO-SEED LINK CARTRIDGE, #10, STERILE | QUICKLINK | BARD BRACHYTHERAPY, INC. -1424526 | KXK | 70302QC10 | UNK | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-12-28 | 0 | 1. R |
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
Patient 1
IT WAS REPORTED THAT THE DEVICE INSTRUCTIONS FOR USE WERE INADEQUATE. ON 11/10/2016, AN ORDER WAS PLACED BY BARD WAREHOUSE (B)(4) FOR QUICKLINKS. THE ORDER WAS DIVIDED INTO 2 ORDERS DUE TO THE VOLUME REQUESTED. THE INTERNATIONAL SALES ORDER NUMBER (B)(4) WAS FOR: 25 STANDARD QUICKLINK#20; 30 QUICKLINK#10; 10 QUICKLINK#20. THE ORDER WAS SHIPPED ON NOV. 11, 2016. THE ORDER COMMENTS/NOTES (SI LINE) WERE INADVERTENTLY ENTERED AS ?SALES SAMPLE. NOT FOR CLINICAL USE? INSTEAD OF ?TEMPERATURE LABELING REQUIRED?. AS A RESULT; A STICKER READING ?NOT FOR CLINICAL USE? WAS PLACED ON THE ORDER WHEN THE ORDER WAS FILLED, TO COMPLY WITH THE SI LINE INSTRUCTIONS. ON 12-7-16, (B)(6) EMAILED CUSTOMER SERVICE OF THE ISSUE AND INQUIRED WHY THE ORDER WAS RECEIVED WITH THE ?SALES SAMPLE. NOT FOR CLINICAL USE? STICKER ATTACHED. HE WAS INFORMED OF THE DATA ENTRY ERROR, AND A REPLACEMENT ORDER WAS SHIPPED THE SAME DAY (12-7-16). THE REPLACEMENT INTERNATIONAL SALES ORDER (SL) WAS (B)(4).
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
Patient 1
IT WAS REPORTED THAT THE DEVICE INSTRUCTIONS FOR USE WERE INADEQUATE. ON (B)(6) 2016, AN ORDER WAS PLACED BY BARD WAREHOUSE (B)(4) FOR QUICKLINKS. THE ORDER WAS DIVIDED INTO 2 ORDERS DUE TO THE VOLUME REQUESTED. THE INTERNATIONAL SALES ORDER NUMBER (SL) (B)(4) WAS FOR: 25 STANDARD QUICKLINK#20; 30 QUICKLINK#10; 10 QUICKLINK#20 THE ORDER WAS SHIPPED ON (B)(6) 2016. THE ORDER COMMENTS/NOTES (SI LINE) WERE INADVERTENTLY ENTERED AS ?SALES SAMPLE. NOT FOR CLINICAL USE? INSTEAD OF ?TEMPERATURE LABELING REQUIRED?. AS A RESULT; A STICKER READING ?NOT FOR CLINICAL USE? WAS PLACED ON THE ORDER WHEN THE ORDER WAS FILLED, TO COMPLY WITH THE SI LINE INSTRUCTIONS. ON (B)(6) 2016, (B)(6) EMAILED CUSTOMER SERVICE OF THE ISSUE AND INQUIRED WHY THE ORDER WAS RECEIVED WITH THE ?SALES SAMPLE. NOT FOR CLINICAL USE? STICKER ATTACHED. HE WAS INFORMED OF THE DATA ENTRY ERROR, AND A REPLACEMENT ORDER WAS SHIPPED THE SAME DAY ((B)(6) 2016). THE REPLACEMENT INTERNATIONAL SALES ORDER (SL) WAS (B)(4).
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
Patient 1
IT WAS REPORTED THAT THE DEVICE INSTRUCTIONS FOR USE WERE INADEQUATE. ON 11/10/2016, AN ORDER WAS PLACED BY BARD WAREHOUSE (B)(4) FOR QUICKLINKS. THE ORDER WAS DIVIDED INTO 2 ORDERS DUE TO THE VOLUME REQUESTED. THE INTERNATIONAL SALES ORDER NUMBER (B)(4) WAS FOR: 25 STANDARD QUICKLINK#20; 30 QUICKLINK#10; 10 QUICKLINK#20. THE ORDER WAS SHIPPED ON NOV. 11, 2016. THE ORDER COMMENTS/NOTES (SI LINE) WERE INADVERTENTLY ENTERED AS ?SALES SAMPLE. NOT FOR CLINICAL USE? INSTEAD OF ?TEMPERATURE LABELING REQUIRED?. AS A RESULT; A STICKER READING ?NOT FOR CLINICAL USE? WAS PLACED ON THE ORDER WHEN THE ORDER WAS FILLED, TO COMPLY WITH THE SI LINE INSTRUCTIONS. ON 12-7-2016, (B)(4) EMAILED CUSTOMER SERVICE OF THE ISSUE AND INQUIRED WHY THE ORDER WAS RECEIVED WITH THE ?SALES SAMPLE. NOT FOR CLINICAL USE? STICKER ATTACHED. HE WAS INFORMED OF THE DATA ENTRY ERROR, AND A REPLACEMENT ORDER WAS SHIPPED THE SAME DAY (12-7-2016). THE REPLACEMENT INTERNATIONAL SALES ORDER (B)(4).
Patient 1
SEVERAL SAMPLES WERE RECEIVED AT BARD BRACHYTHERAPY INC. FOR EVALUATION. THERE WERE 11 UNITS FROM LOT BBAX0053, 13 UNITS FROM LOT BBAX0058, AND 6 UNITS FROM LOT BBAX0054 RECEIVED, AND ALL UNITS WERE LABELED AS INDICATED BY THE PICTURES THAT WERE RECEIVED ORIGINALLY FOR EVALUATION, WHICH DEPICT THE PRODUCT LABELED AS "NOT FOR CLINICAL USE - EVALUATION ONLY." AN ADDITIONAL 10 UNITS FROM LOT BBAX0058 WERE ALSO RECEIVED, BUT THESE LABELS WERE REMOVED FROM EACH UNIT; HOWEVER, IT WAS OBSERVED THAT SOME OF THE LABEL BACKING WAS PRESENT. BASED ON THE PHOTOS PROVIDED AND THE ACTUAL SAMPLES RETURNED FOR EVALUATION, THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE LABELING AFFIXED TO THE PRODUCT INDICATED "NOT FOR CLINICAL USE. FOR EVALUATION ONLY." THIS LABELING WAS FOUND TO BE ADEQUATE, AS THE CUSTOMER DID NOT USE THE PRODUCT. (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
Patient 1
IT WAS REPORTED THAT THE DEVICE INSTRUCTIONS FOR USE WERE INADEQUATE. ON 11/10/2016, AN ORDER WAS PLACED BY BARD WAREHOUSE (B)(4) FOR QUICKLINKS. THE ORDER WAS DIVIDED INTO 2 ORDERS DUE TO THE VOLUME REQUESTED. THE INTERNATIONAL SALES ORDER NUMBER (B)(6) WAS FOR: - (B)(6) STANDARD QUICKLINK#20, - (B)(6) QUICKLINK#10, - (B)(6) QUICKLINK#20. THE ORDER WAS SHIPPED ON NOV. 11, 2016. THE ORDER COMMENTS/NOTES (SI LINE) WERE INADVERTENTLY ENTERED AS ?SALES SAMPLE. NOT FOR CLINICAL USE? INSTEAD OF ?TEMPERATURE LABELING REQUIRED?. AS A RESULT; A STICKER READING ?NOT FOR CLINICAL USE? WAS PLACED ON THE ORDER WHEN THE ORDER WAS FILLED, TO COMPLY WITH THE SI LINE INSTRUCTIONS. ON (B)(6) 2016, (B)(6) EMAILED CUSTOMER SERVICE OF THE ISSUE AND INQUIRED WHY THE ORDER WAS RECEIVED WITH THE ?SALES SAMPLE. NOT FOR CLINICAL USE? STICKER ATTACHED. HE WAS INFORMED OF THE DATA ENTRY ERROR, AND A REPLACEMENT ORDER WAS SHIPPED THE SAME DAY ((B)(6) 2016). THE REPLACEMENT INTERNATIONAL SALES ORDER (SL) WAS (B)(6).