MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,company represent report with the FDA on 2015-07-23 for DEK BL MF 0 FX45 2N 48" BARD DEK200 manufactured by Teleflex Medical.
[15914930]
Alleged event: during a sacro spinal fixation procedure, the bullet broke from the suture and could not be removed from the patient. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
[16356523]
(b)(4). The device history record of batch number 74f1401435 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. The device history review shows that the product was assembled and inspected according to our specifications. Visual inspection was performed using the picture attached to this complaint, pictures reflects a detached bullet. A functional inspection of the product involved in the complaint could not be conducted since the product was not returned. The customer complaint is confirmed based on the picture provided by customer. The root cause is unknown therefore, corrective action cannot be implemented. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[27452053]
(b)(4). Product code dek200 was received; only the bullet section was returned, the suture is missing. Sample was not returned in its original packaging. Process line was verified, and it was reviewed that the process line has all the standards to assure all codes are manufactured on the right conditions. This component (thread) pn: 123074, lot: 74a1400183, dye lot: 74a1400123 are not manufactured at teleflex (b)(4), it comes from a supplier (b)(4). Customer complaint is confirmed based on the condition of the sample received. Photos of sample will be sent to supplier in order to define root cause and corrective actions. Actions to be taken are listed below: determine root cause. Responsible:(b)(4). Due date: (b)(4) 2015.
Patient Sequence No: 1, Text Type: N, H10
[27452054]
Alleged event: during a sacro spinal fixation procedure, the bullet broke from the suture and could not be removed from the patient. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
[30029767]
(b)(4). According the picture provided; the correct lot number is 74f1401435 instead of the lot number reported in description complaint (b)(4). Furthermore, the lot number 74f1401433 is not a valid number in nuevo laredo facility.
Patient Sequence No: 1, Text Type: N, H10
[30029768]
Alleged event: during a sacro spinal fixation procedure, the bullet broke from the suture and could not be removed from the patient. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
[30081938]
(b)(4). 1 sample of product code dek200 was received; only the bullet section was returned, the suture is missing. Sample was not returned in its original packaging. Process line was verified, and it was reviewed that the process line has all the standards to assure all codes are manufactured on the right conditions. This component (thread) pn: 123074, lot: 74a1400183, dye lot: 74a1400123 are not manufactured at teleflex (b)(4), it comes from a supplier (b)(4). Photos of sample were sent to vendor in order to define root cause and corrective actions, per vendor answer: no issues related to their process were identified, therefore; a root cause and corrective action cannot be defined.
Patient Sequence No: 1, Text Type: N, H10
[30081939]
Alleged event: during a sacro spinal fixation procedure, the bullet broke from the suture and could not be removed from the patient. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00196 |
| MDR Report Key | 4936479 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-07-23 |
| Date of Report | 2015-07-08 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-10-29 |
| Date Added to Maude | 2015-07-23 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEK BL MF 0 FX45 2N 48" BARD |
| Generic Name | SUTURE |
| Product Code | OVN |
| Date Received | 2015-07-23 |
| Catalog Number | DEK200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-23 |