MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE-W WINGED PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number	381334
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.Investigation conclusion: the investigation was not able to confirm what customer had experienced as no sample/picture was returned for investigation.End user risk assessment severity per p-eura, (b)(4), for irritation / inflammation is limited (s2) based on the total number of similar complaints received, occurrence = ((b)(4)) x 1,000,000 = (b)(4) ipm which is remote (o2).The risk is acceptable per (b)(4).Root cause description: a review was performed for the last 12 months of quality notification.There was no quality notification was raised for the reported non ¿ conformance.No abnormality was observed during the manufacturing of the batch.If samples are received in the future the complaint will be re-opened and re-investigated.Rationale: the complaint will be monitored and tracked.
Event or Problem Description
It was reported that the patient experienced pain after the insyte-w winged pnk 20ga x 1.16in was used on them for a uterine cavity operation.The physician was consulted, who suggested the patient was experiencing "superficial vein thrombosis".Ointment was applied, as well as a hot compress twice daily.The following information was provided by the initial reporter, translated from chinese to english: uterine cavity after operation on (b)(6) 2020 lines, right wrist department 2 cm - 3 cm with 20 g straight needle in a vein puncture, surgery with propofol, and chlorine xikang, ringo, postoperative wards did not use stimulant drugs, surgery over lien out two days later, did not inform medical staff have any discomfort, (b)(6) puncture blood vessels appeared pain and side, did not see the skin redness, skin temperature is normal, flax, and feel to the hospital to see.And they also invented doctors for consultation tendon, nerve intact, cervical vertebra orthopedic consultation does not appear problem, please the two physician consultation, in the operating room do b to exceed check, suggesting the superficial vein thrombosis, helped him open and completed ointment, twice a day outside, hot compress, during experiencing discomfort to hospital in time, besmear outside effect is not good to hospital to check in three days.

• Brand Name: INSYTE-W WINGED PNK 20GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10492264
• Report Number: 8041187-2020-00539
• Device Sequence Number: 14003054
• Product Code: FOZ
• UDI-Device Identifier: 30382903813347
• UDI-Public: 30382903813347
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• 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
• Report Date (Section B): 08/20/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: 381334
• Device Catalogue Number: 381334
• Device Lot Number: 9326144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/03/2020
• 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: Required Intervention