MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305786
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that before use of the bd luer-lok¿ syringe with detachable needle there was an issue with foreign matter.
Additional Manufacturer Narrative
Investigation summary: dhr for lot number 7303748 was reviewed and no qns or other events were related to the complaint stated by the customer.Material 305786 with lot number 7303748 was manufactured on november 25, 2017.According to sampling plan applied for product performance, this lot was accepted.During manufacturing of this lot number several inspection were performed to the material and no similar issues to the one stated by the customer were found.These inspections were performed by the qa tech and production personnel, during the inspections no issues were found.All relevant information during the dhr review shown that meet all established manufacturing criteria.The sample received was visually inspected and it shows the hair inside the package between the needle and the syringe, on this order it get inspected and packed 50,460 syringes with needles and during the inspection no hair were found on the material.With this condition we can confirm the issue stated by the customer with the sample received from customer, after that we inspect the retain samples, on this case we did not find any failure as the one showed on the sample received from the customer, we can assign this issue as a packaging process issue, looks like the unit was not observed during the inspection process and was packed on the dispenser box, we will inform to the production personnel about this issue, so they can pay special attention at the moment of the inspection of the units, the defect stated by the customer it is confirmed review of pfmea rm5788 was done.A notification was generated to all the production and quality personnel to inform about this issue found with the customer and notify them about the importance to follow the gmp's also this procedure will be scheduled to be recurrent and the personnel be trained every three months.This defect is originated at the moment that the material it is loaded on the packaging cavities, the personnel it is not inspecting the material before it is placed into the cavities also another cause is that the personnel it is not following the gmp's procedure (hair net, gloves, etc.) if this is not followed correctly will cause to have this problem, since that our process is 100 % manual.This defect (foreign matter) was not detected on the inspection performed by the inspection operators and determine the root cause as a packaging process issue.A complaint history check was performed and this is the 1st related complaint reported for the defect/condition stated by customer.There was no report of serious injury or medical/surgical intervention that occurred as a result of this incident.No corrective action it is required at this time.
Event or Problem Description
It was reported that before use of the bd luer-lok¿ syringe with detachable needle there was an issue with foreign matter.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8253572
• Report Number: 9610847-2018-00491
• Device Sequence Number: 19291082
• Product Code: FMI
• UDI-Device Identifier: 30382903057864
• UDI-Public: 30382903057864
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 305786
• Device Lot Number: 7303748
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other