MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) HYPOINT NDL26GA1/2IN; NEEDLE

Catalog Number	300208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: 2pcs of representative samples were received.The samples were inspected for hooked/damaged point(blunt needle).The visual inspection result for the samples is passed.Investigation conclusion: based on the visual inspection of the 2pcs returned samples (representative), there is no hooked/damaged point (blunt needle) observed.Root cause description: dhr reviewed for affected batch number observed no abnormalities that is related to the reported non-conformance.The returned samples (representative) were received and visual inspection was performed.There was no abnormality observed.Hence, root cause could not be established and will continue to monitor the complaint defect trend.Rationale: the root cause could not establish as the returned samples do not observe reported non-conformance.
Event or Problem Description
It was reported that the hypoint ndl26ga1/2in was involved in a case of serious injury -infection which occurred during use.The patient reported "skin and tissue" sticking to the needle after pulling it out, leaving "bloody spots on the abdomen" and a subsequent infection.It has not been specified whether any medical treatment was administered.The following information was provided by the initial reporter: the customer claims that the needle is blunt and difficult to pass through the abdominal wall.When the needle was pulled out, skin and tissue stuck to the needle.There were bloody spots on the abdomen that became infected.

• Brand Name: HYPOINT NDL26GA1/2IN
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9812986
• Report Number: 8041187-2020-00132
• Device Sequence Number: 643282
• Product Code: FMI
• UDI-Device Identifier: 00382903002085
• UDI-Public: 00382903002085
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 300208
• Device Lot Number: 8281157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other