MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 18X1-1/2 BLUNT FILL; MANUAL SURGICAL INSTRUMENT

Catalog Number 305180

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

It was reported when using the bd needle 18x1-1/2 blunt fill, the device experienced damaged unit packaging where sterility of the product is compromised.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: the package was different from usual; red and silver lines were printed and its part was not sealed properly.

Manufacturer Narrative

Investigation summary: it was reported there are red and silver lines printed and the part was not sealed properly.To aid in the investigation, five samples in packaging blisters and three photos were provided for evaluation by our quality team.A visual inspection was performed.The inner side of the packaging top web has two red lines and one silver line the middle the area where these lines are is not sealed.The red and silver lines are part of the splice that connects the two sections of the packaging top web.In this case, when the packaging top web was fed this section with the splice was not removed.No other defects or imperfections were observed.The three photos provided show the sample received.A device history record review was completed for provided material number 305180, lot number 1095827.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the packaging area was performed finding all materials acceptable.To date, there have been no other similar events reported for this lot.The samples were shown to the associates for awareness.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD NEEDLE 18X1-1/2 BLUNT FILL
• Type of Device: MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13238356
• MDR Text Key: 286350387
• Report Number: 1911916-2021-01330
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: 00382903051809
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305180
• Device Lot Number: 1095827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1