MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LS 26X1/2IN INDIA

Catalog Number 303060

Device Problem Fungus in Device Environment (2316)

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

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(4).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 a black dust-like fungus formation was found inside the syringe 1ml ls 26x1/2in india packaging before use.The customer reported 157 occurrences of this event.The following information was provided by the initial reporter: "black dust found inside packing of 1ml syringe.Customer complaint it as fungus formation".

Manufacturer Narrative

Investigation: our quality engineer inspected the returned units and confirmed the reported observations of foreign matter.Black particles were identified on the samples.The particulate was further analyzed and determined to be consistent with polyamide and inorganic compounds.Holes were also observed on the bottom web of the product packaging.This indicates that the foreign matter may have been the results of pest or insect infestation.The pest control report for the bd manufacturing facility was reviewed and showed no reports of pest infestations.The damage may have occurred during transit or storage after the product left the manufacturing facility.The distribution center will be made aware of this complaint.Capa#624191 was initiated.

Event Description

It was reported that a black dust-like fungus formation was found inside the syringe 1ml ls 26x1/2in india packaging before use.The customer reported 157 occurrences of this event.The following information was provided by the initial reporter: "black dust found inside packing of 1ml syringe customer complaint it as fungus formation".

• Brand Name: SYRINGE 1ML LS 26X1/2IN INDIA
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8699933
• MDR Text Key: 149118821
• Report Number: 8041187-2019-00454
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

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: 10/31/2023
• Device Catalogue Number: 303060
• Device Lot Number: 8292017
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other