MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 18X1IN BLUNT FILL; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number	305181
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd needle 18x1in blunt fill foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: the nurse was preparing the reconstitution of a drug and took saline with a needle and syringe.She notices that the saline in the syringe is turning red.She calls one of her colleagues to check.She decides to redo her preparation using new devices which she checks carefully before use.She then notices that the needle still in the bag that she is about to use contains a liquid and dried traces.Again the syringe turns red.The strip test reveals the presence of blood.
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 31-oct-2022.H6: investigation summary: it was reported there was foreign matter in a unit received.To aid in the investigation, one sample with the plastic shield, in an opened packaging blister, and two videos were provided for evaluation by our quality team.Additionally, one 10ml syringe with 4ml of a red substance was provided.A visual inspection was performed and there is a dark foreign matter adhered to the inner wall.The sample was sent to a laboratory for analysis.The laboratory report confirmed foreign matter in the needle hub with the highest match to red grease.This defect could occur if, during the needle hub molding process, lubricant got into the needle hub.One video provided shows the inner part of the needle hub.The other video shows a syringe connected to a needle assembly.The needle assembly is pushed into a bag with solution.When the syringe plunger rod is pulled back, a red solution goes into the syringe.A device history record review was completed for provided material number 305181, lot number 2056692.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 molding process was performed.The molding pressed appeared clean with no residues of lubricant or any other foreign matter.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
It was reported while using bd needle 18x1in blunt fill foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: the nurse was preparing the reconstitution of a drug and took saline with a needle and syringe.She notices that the saline in the syringe is turning red.She calls one of her colleagues to check.She decides to redo her preparation using new devices which she checks carefully before use.She then notices that the needle still in the bag that she is about to use contains a liquid and dried traces.Again the syringe turns red.The strip test reveals the presence of blood.

• Brand Name: BD NEEDLE 18X1IN BLUNT FILL
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• 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: 15695589
• Report Number: 1911916-2022-00595
• Device Sequence Number: 12608589
• Product Code: GAA
• UDI-Device Identifier: 00382903051816
• UDI-Public: 00382903051816
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305181
• Device Lot Number: 2056692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown