MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM N/A 0668945 manufactured by Bard Access Systems.
[186718108]
The information provided by bd 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 bd. The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents. Based on a review of this information, the following was concluded: the complaint of a bent guidewire is confirmed; however, the exact cause is unknown. One 0. 018 in. Guidewire in a plastic hoop was returned for evaluation. An initial visual observation showed the distal end of the guidewire was bent and curved. The blue tip straightener was returned separately from the plastic hoop. A microscopic observation revealed the distal end of the coiled wire of the guidewire was kinked in multiple locations. No use residue was observed on the returned guidewire. While the exact cause of the bends and kinks in the returned guidewire is unknown, possible causes include damage during packaging, handling, or use. The investigation was forwarded to the manufacturing facility for further evaluation. ----------------------------------------------------------------------------------------------------- reynosa evaluation complaint due to? Guide wire was found to be bent? Was confirmed but the exact cause is unknown. According with the photo evaluation performed at reynosa facility and gross visual, microscopic visual performed at vad lab the following was concluded: the guidewire was found to be bent and curled at its distal tip. Damage during the manufacturing process may be a potential root cause/contributor to the observed guidewire kink. However, no findings from the dhr review indicated a manufacturing/processing related event. Possible contributions factors: risks of damage during packaging, clinical procedure, handling or use etc. Were considered. Therefore, as the definitive root cause of this damage could not be determined the cause of this condition remains unknown. A lot history review (lhr) of redp3544 showed one other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[186718109]
It was reported that the guide wire was found to be bent after the package was opened. This made normal use impossible. (b)(6) 2020 - the returned sample had multiple kinks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-01014 |
| MDR Report Key | 9878948 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-07-03 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM |
| Generic Name | INTRODUCER, CATHETER |
| Product Code | DYB |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-02-26 |
| Model Number | N/A |
| Catalog Number | 0668945 |
| Lot Number | REDP3544 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |