MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿

Catalog Number 305959

Device Problems Device Markings/Labelling Problem (2911); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 12/12/2018

Event Type  malfunction  

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 Description

It was reported that bd plastipak¿ hypodermic syringe luer lok¿ had foreign matter and scale marking issue.

Event Description

It was reported that bd plastipak¿ hypodermic syringe luer lok¿ had foreign matter and scale marking issue.

Manufacturer Narrative

Correction: in section h.10 of the previously submitted mdr, sections d.1 and h.1 were incorrectly referenced as the medical device expiration date and device manufacture date.This supplemental mdr is being submitted to correct those references to show the following: d.4 medical device expiration date.H.4 device manufacture date.

Manufacturer Narrative

H.6.Investigation: quantity of customer samples: 1 sealed sample of 10ll lot 1803011 and 2 pictures (1 of a 30ll syringe and 1 of a 10ll syringe).Date customer samples received: 09/dec/2018.It has been received 1 sealed sample of 10ll lot 1803011 and 2 pictures (1 of a 30ll syringe and 1 of a 10ll syringe) for investigation.Upon visual inspection of this sample and picture of 10ll syringe it can be observed that the scale is partially erased in line 0 of the scale.It can also be observed a fiber inside the syringe on the stopper.Upon visual inspection of this sample at 10x it can be confirmed this fiber is polypropylene fiber.This particle comes from molding and transport processes of syringes.The size of this particle is 2,5 mm.According to inspection plan procedure, pp particles >0.8mm inside fluid pad have an aql of 1% (it means an acceptance criteria of 5 defective samples allowed ¿ more than 5 not allowed per lot).Since the occurrence is 1 sample, it meets acceptance criteria.Dhr of lot 1803011 has been reviewed not finding any annotation regarding the alleged defect.According to inspection plan procedure jg-500, 200 units are inspected every 2 pallets by quality control team.In addition, final products in this manufacturing line, for this reference and lot size are sampled by operator and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures (jg-301, jg-302, jg-303 and jg-304): 1.Visual inspection: molding: 2 injections per shift.Printing: 24 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Assembly: 24 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Primary packaging: 1 advance-step (without product) per hour, after any intervention in the equipment, and once at the beginning of the shift.Secondary packaging: 1 shelf-package per pallet.2.Functional inspection: printing: once in the first pallet and once in last pallet of the lot.Assembly: once in the first pallet and once in last pallet of the lot.Primary packaging: once in the first pallet and once in last pallet of the lot.We can confirm that the root cause of the non-conformance is related with transports in manufacturing area.

Event Description

It was reported that bd plastipak¿ hypodermic syringe luer lok¿ had foreign matter and scale marking issue.

• Brand Name: BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8204121
• MDR Text Key: 131709699
• Report Number: 3003152976-2018-00567
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305959
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other