MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOCK SYRINGE; CONVENTIONAL SYRINGE

Catalog Number 301229

Device Problems Contamination /Decontamination Problem (2895); Device Markings/Labelling Problem (2911)

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

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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¿ luer-lock syringe had printing issue and foreign matter.

Event Description

It was reported that bd plastipak¿ luer-lock syringe had printing issue and foreign matter.

Manufacturer Narrative

Investigation: 1 sealed sample of 30ll lot 1804213 and 1 sealed sample of 30ll lot 1803216 and 2 pictures (1 of a 30ll syringe and 1 of a 10ll syringe).Date customer samples received: 09/jan/2019 it has been received 1 sealed sample of 30ll lot 1804213 and 1 sealed sample of 30ll lot 1803216 and 2 pictures (1 of a 30ll syringe and 1 of a 10ll syringe) for investigation.Upon visual inspection of sample from lot 1804213 and picture of 30ll syringe, it can be observed a brown particle and polypropylene particles outside the syringe barrel.Upon visual inspection of the sample of lot 1803216 it can be observed several polypropylene particles outside the syringe.It can be observed this polypropylene particles come from the barrel edge.No marking defect can be observed in any of both syringes.In assembly station of this manufacturing line there is a de-ionizer to reduce foreign matter inside the syringe.Dhr of lot 1804213 has been reviewed not finding any annotation or deviation regarding the alleged defect.Dhr of lot 1803216 has been reviewed finding an annotation regarding the alleged defect.During assembly process of this lot failure was detected in de-ionizing system.Once detected, mechanical team repaired the failure and defective samples detected were rejected to scrap (see attached ot-601767396).On inspection at 10x, it can be observed that these particles from the outside of the syringe are polypropylene material.These particles come from molding and transport processes of syringes that caused they resulted detached from the edge.The size of the longest particle from the syringe of lot 1804213 observed is 1,02 mm and the longest particle from the syringe of lot 1803216 is 1,13mm.According to inspection plan procedure, polypropylene particles (pp) outside the syringe have an aql of 1% (it means an acceptance criteria of 5 defective samples allowed ¿ more than 5 not allowed).Since the occurrence for both defects is 1 defective sample per lot, it meets acceptance criteria.Equipment of manufacturing line is regularly cleaned according to procedure jg-039: once per shift or during any long stop of the manufacturing line.Always any kind of contamination or potential contamination is detected in areas in contact with the product.During mechanical maintenance of the line.Also critical points: during programmed stops of molding machines.Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections by operators during the different manufacturing sub-processes according to procedures 1.Visual inspection molding: 2 injections per shift printing: 10 samples per two hours, after any intervention in the equipment and once at the beginning of the shift assembly: 10 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 two hours, 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 pallet#1, once in pallet#7, once in pallet#14 and once in pallet#22.-assembly: once in pallet#1, once in pallet#7, once in pallet#14 and once in pallet#22.Primary packaging: once in pallet#1, once in pallet#7, once in pallet#14 and once in pallet#22.We can confirm that the root cause of the non-conformance in lot 1803216 is related with the failure in de-ionizer system and the non-conformance in lot 1804213 is related with damage on syringe barrel edge due to transports in manufacturing area that caused polyparticles resulted detached from the barrel edge.

• Brand Name: BD PLASTIPAK¿ LUER-LOCK SYRINGE
• Type of Device: CONVENTIONAL SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8196943
• MDR Text Key: 131493115
• Report Number: 3003152976-2018-00553
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903012299
• UDI-Public: 382903012299
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

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
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 301229
• Device Lot Number: 1804213
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other