MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK¿ TIP SYRINGE

Catalog Number 309604

Device Problem Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7264532; medical device expiration date: 2022-09-30; device manufacture date: 2017-10-27; medical device lot #: 7319660; medical device expiration date: 2022-11-30; device manufacture date: 2018-01-04.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the packaging on bd luer-lok¿ tip syringe(s) tore, causing possible sterility issues.There was report of injury or medical interventions.

Manufacturer Narrative

Investigation summary: samples received from the customer (41 pieces of batch 7319660) and retention samples (20 pieces per batch) are evaluated for the length test of the opening tab, in all the functional tests there are conformity results.So the claim is not confirmed and it is attributed that the event is presented by an inadequate opening of the packaging.The lots were manufactured in line 6 in 2 days during which the production is monitored through the frequency rit0225ctis01-04 rev.17, where characteristics were evaluated in the packing stage such as: blister cut suitable to the catalog (visual method vs drawing), perimeter seal less than 3 mm and continuous (measurement method with calibrated rule), correct longitudinal cut (visual method), packaging with peel apart (visual method), integrity of the primary packaging: blister without perforations, seal not open or seal without wrinkles (visual method), during the frequency take 40 pieces per hour, completing a total sample size of 1,120 pieces with an acceptance limit of 0 and rejection of 1.Additional process parameters are reviewed all are within of the operation window and almost in the middle of it.The final batch was inspected by quality control, taking a sample of 120 pieces with an acceptance criterion with 1 rejection and with 0 obtaining conforming results within an aql = 0.25%, for which the batch was approved and inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests.Investigation conclusion: unconfirmed.It is attributed to an inadequate opening of the packaging.

Event Description

It was reported that the packaging on bd luer-lok¿ tip syringe(s) tore, causing possible sterility issues.There was report of injury or medical interventions.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.

Event Description

It was reported that the packaging on bd luer-lok¿ tip syringe(s) tore, causing possible sterility issues.There was report of injury or medical interventions.

• Brand Name: BD LUER-LOK¿ TIP SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 7475648
• MDR Text Key: 107703370
• Report Number: 9614033-2018-00018
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096047
• UDI-Public: 30382903096047
• Combination Product (y/n): N
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309604
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other