MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Model Number	305908
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fmi, common device name: hypodermic single lumen needle, pma / 510(k)#: k951254.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that needle was discovered to be broken prior to use with a 1 ml bd safetyglide¿ insulin syringe with attached needle.The following information was provided by the initial reporter: broken needle.
Event or Problem Description
It was reported that needle was discovered to be broken prior to use with a 1 ml bd safetyglide¿ insulin syringe with attached needle.The following information was provided by the initial reporter: broken needle.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/26/2020.H.6.Investigation: customer returned (1) 10 ml, 40mm, 22g bd safetyglide syringe with an opened blister pack from lot # 9031536.Customer states that the needle is broken.The returned syringe was examined and exhibited a bent cannula.Based on the samples and/or photo(s) received the investigation concluded that bd was able to duplicate or confirm the indicated failure.Root cause: bent during use of the product by the customer.A review of the batch history record for the complaint lot was satisfactory and there were no related quality notifications.H3 other text : see h.10.

• Brand Name: 1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10448161
• Report Number: 9610847-2020-00258
• Device Sequence Number: 2676675
• Product Code: FMF
• UDI-Device Identifier: 30382903059080
• UDI-Public: 30382903059080
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: 12/31/2023
• Device Model Number: 305908
• Device Catalogue Number: 305908
• Device Lot Number: 9031536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/30/2020
• 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