MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	300208
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd hypoint needle foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: we have to inform you that we have been informed by our customer that the glue on the received needle is too far towards the tip of the needle.Please let us know if it is safe to use such needles or not, because the glue is also in contact with the puncture site.We urgently need an official statement from you confirming the safety (if this is the case).Is there also a specification of the needle that reflects the amount of adhesive? there is the authority (regierung oberbayern) involved.Therefore we need a feedback / statement from you until next friday ((b)(6) 2023).
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4: medical device lot #: 1160130.D4: medical device expiration date: 30jun2026.H4: device manufacture date: 18aug2021.H6: investigation summary the customer issued a complaint for glue on the received needle is too far towards the tip of the needle detected at market.No samples were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Four (4) photos were provided for investigation.Epoxy trailing is observed on the cannula of the photos received, however, the length of the trailing could not be determined from the photos provided.Samples are required to delve into the investigation and root cause analysis regarding epoxy trailing.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.As this is a market event, the reported condition detected is not part of a sampling plan that allows to conclude about the whole batch, therefore the aql is not applicable.The batch was manufactured and released according to applicable procedures and specifications.Consequently, bdm-ps will not define corrective or preventive actions following the investigation of this complaint.This complaint is registered in bd complaint system and trend analysis will be performed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 19-sep-2023 h6: investigation summary the customer issued a complaint for glue on the received needle is too far towards the tip of the needle detected at market.Four (4) photos were provided for investigation.Epoxy trailing is observed on the cannula of the photos received, however, the length of the trailing could not be determined from the photos provided.Three (3) samples were provided for this complaint.All three (3) samples were measured on the epoxy trailing.The epoxy trailing of all three (3) samples were less than 4mm.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.As this is a market event, the reported condition detected is not part of a sampling plan that allows to conclude about the whole batch, therefore the aql is not applicable.The batch was manufactured and released according to applicable procedures and specifications.H3 other text : see h10.
Event or Problem Description
It was reported while using bd hypoint needle foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: we have to inform you that we have been informed by our customer that the glue on the received needle is too far towards the tip of the needle.Please let us know if it is safe to use such needles or not, because the glue is also in contact with the puncture site.We urgently need an official statement from you confirming the safety (if this is the case).Is there also a specification of the needle that reflects the amount of adhesive? there is the authority (regierung oberbayern) involved.Therefore we need a feedback / statement from you until next friday ((b)(6) 2023).

• Brand Name: BD HYPOINT NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17627826
• Report Number: 8041187-2023-00455
• Device Sequence Number: 15300355
• Product Code: FMI
• UDI-Device Identifier: 00382903002085
• UDI-Public: (01)00382903002085
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K070440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 300208
• Device Lot Number: 9135940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown