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	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 with the use of the bd luer-lok¿ syringe with detachable needle there was an issue with syringe not being fully tight with needle.
Event or Problem Description
It was reported with the use of the bd luer-lok¿ syringe with detachable needle there was an issue with syringe not being fully tight with needle.It was reported that 50 devices were affected.
Additional Manufacturer Narrative
Describe event or problem: it was reported with the use of the bd luer-lok¿ syringe with detachable needle there was an issue with syringe not being fully tight with needle.It was reported that 50 devices were affected.Investigation summary: the samples received from the customer were visually inspected for any damage that they could have and the only place found with some tearing was the area of the luer connection on both needles received.This tear was done at the moment the needle and the syringe were assembled together and when the luer connection was tightened the treads were loosed, this is the condition that the customer find on the material.With this condition we can confirm the issue stated by the customer on the two samples received, after that we assembled the retain samples we have and perform the same test, we assembled 10 pieces of the needle and the syringe but on this case we did not find any failure as the one showed on the samples received from the customer, we can assign this issue as a material defect, due that our process it is only packaging, we place the needle and the syringe on a blister and then it is sealed and packed, we do not perform any kind of test during this process.The defect stated by the customer it is confirmed.Reviewing our pfmea¿s rm5788, there are proper controls in place to detect packaging product malfunctions.We could not determine the root cause as a manufacturing defect, it can be assign it as a material or end user issue, due that during the assembly of the retention samples we could not replicate the defect found by the customer.Material 305224 with lot number 8221608 was manufactured on august 21, 2018.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.

• 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: 8186840
• Report Number: 9610847-2018-00427
• Device Sequence Number: 2266307
• Product Code: FMI
• UDI-Device Identifier: 00382903057863
• UDI-Public: 00382903057863
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/23/2019

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: 07/31/2023
• Device Catalogue Number: 305786
• Device Lot Number: 8221608
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/24/2019
• 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